The Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis

Comparison of the Efficacy and Complication of Gentamicin and Normal Saline Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis : a Double Blind Randomized Control Trial

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02582099

Enrollment

Registered

2015-10-21

Start date

2017-01-01

Completion date

2019-06-30

Last updated

2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinosinusitis

Brief summary

Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.

Detailed description

Chronic rhinosinusitis (CRS) is characterized by symptoms \> 12 weeks.Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure reduction or loss of smell). Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics. Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis. Gentamicin irrigation should be helpful in chronic rhinosinusitis.

Interventions

DRUGGentamicin nasal irrigation

Nasal wash with gentamicin solution

DRUGNormal saline nasal irrigation

Nasal wash with normal saline solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

7 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Chronic rhinosinusitis and/or recurrent acute/subacute sinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between December 4, 2012, and December 3, 2016

Exclusion criteria

1. Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation 2. Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation 3. Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation 4. Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation 5. Patient who have mental retardation 6. Patient who have aminoglycosides hypersensitivity reactions 7. Pregnancy women and Lactation period 8. Patient who have abnormal hearing test before started gentamicin nasal irrigation 9. Patient who have chronic rhinosinusitis with nasal polyp

Design outcomes

Primary

Measure	Time frame
Frequency of sinusitis	During 1 year after treatment

Countries

Thailand

Contacts

Primary ContactNualanong Visitsunthorn, Professor

nualanongv@yahoo.com+6624195670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026